FDA grants approval for Barr, Duramed's Seasonique extended-cycle oral contraceptive

By Lisa Kerner

Erie, Pa., May 25 - Barr Pharmaceuticals, Inc. said the Food and Drug Administration has approved Duramed Pharmaceuticals, Inc.'s New Drug Application for Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive for the prevention of pregnancy.

Seasonique will be shipped to trade customers and will be available by prescription to women in July, according to a company news release. The low-dose estrogen Seasonique provides continuous hormonal support in place of seven placebo pills.

Barr plans to begin multiple marketing programs aimed at both health care providers and patients.

"We believe that our Seasonique product line, including our Lo Seasonique product that is currently in phase 3 clinical studies, as well as other extended-cycle oral contraceptive products also in development, expands our commitment and leadership to a franchise that provides women with the option of four periods per year and low dose estrogen instead of a hormonal free interval," chairman and chief executive officer Bruce L. Downey said in the release.

Barr, a holding company for Duramed Pharmaceuticals, Inc., develops, manufactures and markets generic and proprietary pharmaceuticals in Woodcliff, N.J.

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